The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

A SWINE flu vaccine has been approved by the Therapeutic Goods Administration, (Australian) federal Health Minister Nicola Roxon has confirmed.

The vaccine, developed by pharmaceutical firm CSL, will be available later in September.

Ms Roxon said there was enough vaccination available for all adults.

"I encourage people to now take the opportunity to protect themselves and their families against the pandemic flu by getting vaccinated," she told reporters in Canberra on Friday.

Ms Roxon said issues concerning multi-dose vials and indemnity have both been resolved.

"The government from day one has been determined to combat this disease in a sensible, clear and direct way," she said.

"The vaccine now is our best defence against the pandemic flu."

She said while the virus has been mild for most people, it has had severe effects on more than 100 children.

She said the flu has been associated with thousands of hospitalisations and 172 deaths in Australia.

Worldwide there have been 3,500 deaths associated with the virus.

The vaccine will first be available only to adults, with the TGA awaiting further data from clinical trials before determining whether it is safe for children.

"This registration announcement today marks the commencement of the vaccination program for adults," Ms Roxon said.

"The TGA is awaiting further data from CSL trials of the vaccine for children aged nine and under, and therefore has not yet made a decision on the use of the vaccine in children, but this is expected in the near future."

The Rudd government has already purchased 21 million doses of the vaccine with four million of those stored in CSL warehouses.

Deliveries of the vaccine to immunisation providers will begin from next week.

Ms Roxon said the vaccination program would be the largest in the nation's history with the initial rollout to focus on protecting frontline health workers and those most at risk.

"The priority groups for vaccination are frontline healthcare and community care workers who have direct contact with patients, people with underlying medical conditions such as asthma, cancers, HIV, heart disease, diabetes and chronic kidney failure."

Ms Roxon said people who are obese, indigenous Australians, children in special schools aged over nine, pregnant women and parents and guardians of children aged up to six would also receive priority care.

The vaccination will not be mandatory.

The vaccine will be available from September 30.

Ms Roxon said there would be some delays getting the vaccines to rural and regional areas, adding the sparsely populated state of Western Australia had planned its own distribution program.

"We're in the fortunate position, given advice from CSL, that there is only one dose required for adults, which means we will be able to vaccine anybody in the community who wants to be vaccinated," Ms Roxon.

Adult Australians at risk of contracting swine flu have been urged to get vaccinated, and would be able to access the dose quickly, the minister said.

General practices have on their records "clear information" to enable them to contact patients.

"Some will provide the vaccination as people present. Others will organise actual clinic days to call people in," Ms Roxon said.

Ms Roxon was unable to put a precise figure on the cost of the vaccine.

"There are some confidentiality issues. We have a private contractual agreement with CSL for the priority provision for this vaccine," she said.

"I have made clear on the record before that it is over $100 million. It is not appropriate for us to be itemising the exact cost, given the commercial interests that are also at stake."

Chief medical officer Jim Bishop said trials showed the vaccination would give a high level of protection with one dose for the next flu season "and beyond".

In the temperate regions* of the northern hemisphere, influenza activity remains widely variable. In North America, the United States is reporting increases in influenza-like-illness activity above the seasonal baseline, most notably in the southern, southeastern, and parts of the northeastern United States.

Each week CDC analyzes information about influenza disease activity in the United States and publishes findings of key flu indicators in a report called FluView. During the week of September 6-12, 2009, a review of the key indictors found that influenza activity continued to increase in the United States compared to the prior weeks.

Updated Interim Recommendations for Obstetric Health Care Providers Related to Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season Thu, 17 Sep 2009 23:30:00 -0500

Pregnant women are at higher risk for severe complications and death from influenza, including both 2009 H1N1 influenza and seasonal influenza. Treatment with oseltamivir (Tamiflu®) or zanamivir (Relenza®) is recommended for pregnant women with suspected or confirmed influenza and can be taken during any trimester of pregnancy. The duration of antiviral treatment is 5 days. See Table 1 (below) for dosing information.

Why does CDC recommend that pregnant women receive the 2009 H1N1 influenza vaccine? Is there a particular kind of flu vaccine that pregnant women should get? Are there flu vaccines that pregnant women should not get?

This report provides an update to the international situation as of September 18, 2009. As of September 13, 2009, the World Health Organization (WHO) regions have reported more than 296,471 laboratory-confirmed cases of 2009 H1N1 influenza virus (2009 H1N1) with at least 3,486 deaths, which is an increase of at least 18,864 cases and 281 deaths since September 6th.

Pandemic flu infections throughout North Carolina are so widespread that doctors and hospitals are dealing with an outbreak more typical of January or February, when seasonal flu spikes.And it's only September.

"Right now we're in the midst of a second wave," said Dr. Jeffrey Engel, state health director. He said this wave -- the first hit in May when the novel H1N1 erupted before tailing off in the summer -- is likely to remain at a peak for a while.

By the numbers1,125: Number of flu-like infections reported the week of Sept. 5

5.9: Percentage of doctor visits that were due to flu that week

217: Number of hospitalizations since May

11: Death toll since May

SOURCE: N.C. Division of Public Health

For the first week of September, the state reported 1,125 cases of flu-like illness through its network of doctors' offices, clinics and hospitals that participate in a surveillance system. Most of those illnesses are attributed to the H1N1 virus.At its worst last winter, seasonal flu hit 719 people in North Carolina during one week in February.

Engel said he expects there will be a third wave of the pandemic flu, and it's likely to strike at the same time that seasonal flu begins circulating this winter.

As a result, he said, people should take advantage of vaccination programs, both for seasonal flu and the H1N1 strain. Engel said the state has received $23 million in federal funds to help counties conduct flu vaccine clinics for the pandemic strain, because the shots will have to be delivered separately from seasonal inoculations.

Engel said he expects the H1N1 vaccine to be available in early October, although it will initially be given to people who are at highest risk of developing complications.

Among those most vulnerable to serious complications are pregnant women, people with chronic diseases such as asthma and diabetes, and children.

Dr. Megan Davies, state epidemiologist, said pregnant women are an especially critical population, and public health teams are working to get obstetricians to encourage vaccination.

According to recent analyses, 6 percent of patients who died from H1N1 infections in the early outbreak were pregnant women.

Clinical trials on the vaccine are under way. At Duke University Medical Center, doctors begin a trial today, hoping to enroll about 20pregnant women to help test dosage levels.

"It's really very similar to standard seasonal flu vaccine," said Dr. Geeta Swamy, who is helping lead the trial. "It's just a strain change."

Mere,This is scarey stuff. My 16 yo daughter just got out of the hospital Friday with swine flu and pneumonia(she is the first hospitalized child in our area)....my 23 yo daughter (asthma patient)was also treated but sent home instead of put in hospital. Younger daughter doing much better but older daughter still not doing so good.....WASH HANDS LOTS, and stay hydrated!!!! Praying for Good health to all.

MunkeyMunk....thank you for sharing....I hope both of your children will be well very soon. Please share with us anything that you think might help the rest of the group.

Washing hands or using Purell-type Hand Sanitizer at every sink and workplace (I carry small one in purse), carry tissues with you or cough in sleeve, avoid crowds and/or people who are ill. Keep your home and workplace wiped clean with chlorox-type wipes. Do not go to work if you are sick. Do not send your child to school if they are sick. Keep hydrated.

Find out what is going on in your community by reading here and searching H1N1 flu for your State.

MunkeyMunk....thank you for sharing....I hope both of your children will be well very soon. Please share with us anything that you think might help the rest of the group.

Washing hands or using Purell-type Hand Sanitizer at every sink and workplace (I carry small one in purse), carry tissues with you or cough in sleeve, avoid crowds and/or people who are ill. Keep your home and workplace wiped clean with chlorox-type wipes. Do not go to work if you are sick. Do not send your child to school if they are sick. Keep hydrated.Find out what is going on in your community by reading here and searching H1N1 flu for your State.

This is a serious illness if you or a family member develops it.

those are the exact things her DR told us!! He said keeping hands clean was the MAIN one just watch yourself sometime at how many times you touch your face in a day. I counted 11 times in an hour the other day after he said that....

September 23, 2009I went to Afghanistan and all I got was H1N1Posted: 09:51 AM ETBy Dr. Sanjay GuptaCNN Chief Medical Correspondent

It started as a cough. It wasn’t the kind of cough where something is temporarily stuck in your throat. It wasn’t the kind of cough where simply clearing your throat would’ve been adequate. This was the kind of cough that hurts when you do it. A stinging pain that makes you wince and guard and hope that you don’t have to cough again any time soon. I thought I might have a fever, but of course, I was in the middle of covering a war in Afghanistan, and the conditions were… well, hot. So, maybe it was that. Problem was, the next day I wasn’t feeling any better – in fact, I was worse. I woke up in my dusty desert tent and tried to step out of my sleeping bag. Two steps later, I almost hit the deck. Incoming. Except this wasn’t due to any sirens going off, this was due to my own body simply being unable to hold myself up. I was lightheaded and freezing cold – even though it was over 100 degrees outside at that early hour of the morning.

I was nauseated and my entire body hurt. I tried to explain away my symptoms with lots of different excuses. You don’t sleep much while covering a war. My bulletproof jacket didn’t fit perfectly and was very heavy. There was a lot of dust and dirt, and maybe I had what the Marines referred to as the Kandahar Krud. It turned out to be none of those things.

I remember looking over at my camera man, Scottie McWhinnie. He looked absolutely awful. He was wearing a scarf on his head, and it was completely drenched in sweat. He was coughing so loudly and frequently that I was really starting to worry about him – and about myself. We each had it, whatever “it” was. I made a command decision. As a physician reporter in a war zone, I was going to get us medical care. That prompted our visit to a battlefield hospital, not as reporters this time, but as patients.

It is worth pointing out the irony of a medical reporter getting influenza type A, which was then ultimately confirmed as H1N1. (The term swine flu is a misnomer, as this strain is made up of several different components, including swine, but also avian parts.) It really didn’t matter if I got tested, as my doctor told me. It was the only flu strain circulating and I had it, and so did Scottie. We both had high fevers, the lack of appetite, terrible sinus congestion, body aches, and yes – that hacking, come out of the blue.

I am not someone who gets sick, really ever. And this was the sickest I have ever been. I would’ve much preferred my own bed with all the comforts of home – including a wife who would’ve taken great pity on me and allowed me lots of rest and relaxation. Still, I am here to blog about it, after taking the requisite few days to stay at home and not spread my gift from Afghanistan to all my colleagues at work. In case you are curious, there wasn’t much the doctors could really do for me. Some Tylenol and a sinus decongestant (the same my wife would’ve given me). We also got IV fluids, given our inability to keep anything down. Within a couple days, I felt a lot better, and a few days after that – I was back to normal. It was a lot like… the flu – with a different name. A lot of people will get the exact symptoms I described above, and for most people, it will simply mean a few miserable days, hopefully spent in your home – and not in a war zone.

Regulatory authorities have licensed pandemic vaccines in Australia, China, Hungary and the United States of America, soon to be followed by Japan and several countries in Europe. The length of the approval process depends on factors such as each country's regulatory pathway, the type of vaccine being licensed, and the stage of manufacturers' readiness to submit appropriate information to regulatory authorities.

As of September 18, 2009 influenza activity is increasing in most of the United States with 21 states reporting widespread influenza activity. So far, most influenza viruses isolated are 2009 H1N1 flu (sometimes called "swine flu"), the virus that has been declared pandemic by the World Health Organization. CDC expects both 2009 H1N1 flu and seasonal flu to cause illness, hospital stays and deaths this influenza season and while influenza is unpredictable, it’s possible the United States could experience an early, prolonged and severe influenza season.

This report provides an update to the international situation as of September 25, 2009. As of September 20, 2009, the World Health Organization (WHO) regions have reported at least 318,925 laboratory-confirmed cases of 2009 H1N1 with more than 3,917 deaths, which is an increase of at least 22,454 cases and more than 431 deaths since September 13th.